HealthyPhase 1NCT01121380
A Study Intended to Evaluate Safety, Tolerability and Pharmacokinetics (PK) Parameters of BL-1021
A Phase 1 study testing BL-1021 and 1021 in people with Healthy and Volunteers, run by BioLineRx, Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to test the safety, tolerability and pharmacokinetics of BL-1021 in healthy volunteers. Subsequent clinical studies will be designed to test the safety and efficacy of BL-1021 in patients with neuropathic pain based on data obtained from the proposal trial described below. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Volunteers
- What is being tested?
- BL-1021 and 1021
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Evidence or history of significant concomitant disease (including mental, CNS-related, renal, hepatic, cardiovascular, pulmonary disease, or other)
- Prior or current history of cancer, except for cured basal cell carcinoma of the skin
- History of significant abnormalities in ECG, including QT prolongation
- History of significant neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm (especially melanoma), or any other clinically significant medical disorder, which in the Investigator's judgment contraindicate administration of the study medications
- Use of another investigational medication/treatment in the past 30 days
- History of drug or alcohol abuse
Show all 20Show fewer
- Significant abnormalities in screening physical examination
- Significant abnormalities in clinical laboratory parameters (hematology, biochemistry, serology, urinalysis)
- History of gastrointestinal disorder likely to influence drug absorption
- Consumption of Serotonin-Norepinephrine Reuptake Inhibitors (SNRI's), selective serotonin reuptake inhibitors (SSRI's), tricyclic/tetracyclic antidepressants within 90 days prior to Day 0
- Consumption of drugs that may potentially inhibit or induce liver cytochrome P450 activity within 3 weeks prior to Day 0
- Subjects who are either extensive-extensive metabolizers (i.e. carriers of multiple CYP2D6 gene copies) or poor metabolizers of CYP 2D6 will be excluded.
- Any acute medical situation (e.g. acute infection) within 48 hours of Day 0, which is considered of significance by the Principal Investigator
- Unusual diet
- Sero-positive HIV, HBSAg or HCV
- Donation of 450ml or more blood within the previous 12 weeks
- Probability of undertaking intense physical activity throughout the study duration (Single Dose: Day 0 - Day 8, Multiple Dose: Day 0 - Day 14)
- Any condition, which in the opinion of the Principal Investigator would place the subject at risk or influence the conduct of the study or interpretation of results
- Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function)
- Subjects who, in the judgment of the investigators, are likely to be non-compliant or uncooperative or unwilling to sign a consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-Human, Randomized, Double-Blind, Placebo Controlled, Single-Center Combined Single-Ascending Dose and Multiple-Ascending Dose, Parallel Groups, Study to Assess Safety, Tolerability and Pharmacokinetics of BL-1021 in Healthy Volunteers
The purpose of this study is to test the safety, tolerability and pharmacokinetics of BL-1021 in healthy volunteers. Subsequent clinical studies will be designed to test the safety and efficacy of BL-1021 in patients with neuropathic pain based on data obtained from the proposal trial described below.
Read the detailed description
A total of 32 subjects in the single-ascending phase and 24 subjects in the multiple ascending phase, who have provided a written informed consent and comply with inclusion/exclusion criteria will participate in the study in 4 different cohorts in the first phase (cohorts A, B, C and D) and 3 different cohorts in the second phase (cohorts E, F and G), each consisting of 8 subjects.
First part dosing:
Cohort A - 10 mg Cohort B - 20 mg Cohort C - 30 mg Cohort D - 40 mg
Second part dosing:
Cohort E - X mg (X shall be determined using the results of the 1st part) Cohort F - 2X mg Cohort G - 4X mg
- Conditions
- Healthy, Volunteers
- Being tested
- BL-1021, 1021
- Keywords
- Healthy, Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-1021Drug
BL-1021 is an orally available NCE which contains an elongated aliphatic side-chain.
Dosage:
Part 1 - Single Dose: 1 dose on Day 1, dosage will be 10, 20, 40 \& 80 mg according the cohort Part 2 - Multiple Dosing: up to 7 once-daily administrations. Dosage will be determined according the first part results.
1021Drug
1021
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - 10 mg | Experimental | Not described Receives: Drug: BL-1021; Drug: 1021 |
| Cohort B - 20 mg | Experimental | Not described Receives: Drug: BL-1021; Drug: 1021 |
| Cohort C - 40 mg | Experimental | Not described Receives: Drug: BL-1021; Drug: 1021 |
| Cohort D - 80 mg | Experimental | Not described Receives: Drug: BL-1021; Drug: 1021 |
| Cohort E - X mg | Experimental | Part 2, multiple dose. X shall be determined using the results of part 1. Receives: Drug: BL-1021; Drug: 1021 |
| Cohort F - 2X mg | Experimental | Part 2, multiple dose. X shall be determined using the results of part 1. Receives: Drug: BL-1021; Drug: 1021 |
| Cohort G - 4X mg | Experimental | Part 2, multiple dose. X shall be determined using the results of part 1. Receives: Drug: BL-1021; Drug: 1021 |
| Placebo | Placebo comparator | In each cohort there is a placebo arm Receives: Drug: 1021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Part 1 and 2
Secondary outcomes (4)
Mean change from baseline in vital signs
Measured: Part 1 and 2
Mean change from baseline in laboratory parameters
Measured: Part 1 and 2
Cmax, Tmax, AUCT, AUCI, kel, T½
Measured: Part 1 and 2
Dose linearity of PK parameters
Measured: part 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Sponsor strategy change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioLineRx, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yotam Nisemblat, Study director, BioLineRx, Ltd.Yoseph Caraco, Prof, MD, Principal investigator, Hadassah Clinical Research Center (HCRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121380
- Sponsor's protocol ID
- BL-1021.01
- Status last verified
- Mar 2014
- First submitted
- 10 May 2010
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Randomized, Double-Blind, Placebo Controlled, Single-Center Combined Single-Ascending Dose and Multiple-Ascending Dose, Parallel Groups, Study to Assess Safety, Tolerability and Pharmacokinetics of BL-1021 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01121380
- Acronym / sponsor ID
- BL-1021.01
- Conditions
- Healthy, Volunteers
- Keywords
- Healthy, Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor strategy change
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BioLineRx, Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 12 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety, tolerability and pharmacokinetics of BL-1021 in healthy volunteers. Subsequent clinical studies will be designed to test the safety and efficacy of BL-1021 in patients with neuropathic pain based on data obtained from the proposal trial described below.
Detailed description
A total of 32 subjects in the single-ascending phase and 24 subjects in the multiple ascending phase, who have provided a written informed consent and comply with inclusion/exclusion criteria will participate in the study in 4 different cohorts in the first phase (cohorts A, B, C and D) and 3 different cohorts in the second phase (cohorts E, F and G), each consisting of 8 subjects.
First part dosing:
Cohort A - 10 mg Cohort B - 20 mg Cohort C - 30 mg Cohort D - 40 mg
Second part dosing:
Cohort E - X mg (X shall be determined using the results of the 1st part) Cohort F - 2X mg Cohort G - 4X mg
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort A - 10 mg | Experimental | Drug: BL-1021, Drug: 1021 |
| Cohort B - 20 mg | Experimental | Drug: BL-1021, Drug: 1021 |
| Cohort C - 40 mg | Experimental | Drug: BL-1021, Drug: 1021 |
| Cohort D - 80 mg | Experimental | Drug: BL-1021, Drug: 1021 |
| Cohort E - X mg | Experimental | Drug: BL-1021, Drug: 1021Part 2, multiple dose. X shall be determined using the results of part 1. |
| Cohort F - 2X mg | Experimental | Drug: BL-1021, Drug: 1021Part 2, multiple dose. X shall be determined using the results of part 1. |
| Cohort G - 4X mg | Experimental | Drug: BL-1021, Drug: 1021Part 2, multiple dose. X shall be determined using the results of part 1. |
| Placebo | Placebo comparator | Drug: 1021In each cohort there is a placebo arm |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- Evidence or history of significant concomitant disease (including mental, CNS-related, renal, hepatic, cardiovascular, pulmonary disease, or other)
- Prior or current history of cancer, except for cured basal cell carcinoma of the skin
- History of significant abnormalities in ECG, including QT prolongation
- History of significant neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm (especially melanoma), or any other clinically significant medical disorder, which in the Investigator's judgment contraindicate administration of the study medications
- Use of another investigational medication/treatment in the past 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-1021BL-1021 is an orally available NCE which contains an elongated aliphatic side-chain. Dosage: Part 1 - Single Dose: 1 dose on Day 1, dosage will be 10, 20, 40 \& 80 mg according the cohort Part 2 - Multiple Dosing: up to 7 once-daily administrations. Dosage will be determined according the first part results. | Drug | Cohort A - 10 mg, Cohort B - 20 mg, Cohort C - 40 mg, Cohort D - 80 mg, Cohort E - X mg, Cohort F - 2X mg, Cohort G - 4X mg |
| 10211021 | Drug | Cohort A - 10 mg, Cohort B - 20 mg, Cohort C - 40 mg, Cohort D - 80 mg, Cohort E - X mg, Cohort F - 2X mg, Cohort G - 4X mg, Placebo |
Primary outcome
Incidence of adverse events
Time frame: Part 1 and 2
4 secondary outcomes
Mean change from baseline in vital signs
Time frame: Part 1 and 2
Mean change from baseline in laboratory parameters
Time frame: Part 1 and 2
Cmax, Tmax, AUCT, AUCI, kel, T½
Time frame: Part 1 and 2
Dose linearity of PK parameters
Time frame: part 1 and 2
Results and safety
The study was stopped early (reason given: Sponsor strategy change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yotam Nisemblat study director
BioLineRx, Ltd.
Yoseph Caraco, Prof, MD principal investigator
Hadassah Clinical Research Center (HCRC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BL-1021 and 1021 in people with Healthy and Volunteers, run by BioLineRx, Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor strategy change). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Part 1 and 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.